For many in the life sciences industry, the regulatory approval process of the U.S. Food and Drug Administration (FDA) lacks predictability and transparency when it comes to product development. This lack of predictability and transparency directly translates into added costs for companies seeking regulatory approval of products and delay in time to market, which ultimately has an adverse impact on innovation, patient care, and jobs. Until now, this position has only been supported by anecdotal evidence.

With the help of industry, including Wilson Sonsini Goodrich & Rosati, the Medical Device Manufacturers Association (MDMA) provided the FDA with a number of examples of how current FDA policies and practices hamper innovation by creating unnecessary burdens on companies trying to innovate. In response, the FDA asked the MDMA to generate data to support the industry’s concerns. As a result, the MDMA, in conjunction with the National Venture Capital Association, Dr. Josh Makower, and Aabed Meer, developed a survey and deployed it to the MDMA’s members—amounting to more than 200 smalland medium-sized medical technology companies—to quantify the impact that the FDA is having on the medical device industry. Of particular interest, the study reported the following...